Kornimate/medical-research-clean huggingface dataset:
trancutaneous monitoring to avoid hypercapnea during complex catheter ablations

Conditions: Hypercapnia

Summary: use of trancutaneous co2 (tc02) monitoring to aide in titration of sedation of midazolam and fentanyl. trancutaneous readings validated with invasively obtained specimens from existing arterial sheaths required during af and vt ablations (trans-septal and retrograde aortic respectively)

cardiac electrophysiology procedures are typically performed under moderate (conscious) sedation in most centers. advantages over general anesthesia include facilitating arrhythmia induction, avoidance of intubation and ventilator related complications and shorter post-procedure recovery times for most patients. however, the cumulative respiratory depressant effects of fentanyl and midazolam during prolonged procedures can rarely cause hypoventilation resulting in hypercapnea and respiratory failure. complex catheter ablations for atrial fibrillation and ventricular tachycardia can exceed 3-5 hours in duration requiring large cumulative doses of midazolam and fentanyl. end tidal co2 monitors, particularly in non-ventilated patients, have limitations and obtaining frequent arterial blood gas samples are often impractical. it remains unknown if contemporary trancutaneous co2 monitoring (tco2)can provide a feasible alternative to avoid over-sedation and resultant respiratory complications during complex catheter ablations with sufficient agreement to invasively obtained pco2 data.

Eligibility criteria:
inclusion criteria: * patients undergoing catheter ablation for atrial fibrillation (af) or ventricular tachycardia (vt) under moderate sedation. exclusion criteria: * procedures scheduled for general anesthesia
diagnostic performance of a new bio-marker during bacterial sepsis

Conditions: Sepsis

Summary: sepsis is a constant concern in icu, frequent and severe, it requires early diagnosis and prompt implementation of the etiological treatment. the bacterial infections are the most common and are associated with high morbidity and mortality. diagnosis is based on the detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor antibiotic treatments. blood cultures are positive in 30-35% of cases and diagnosis is often based on a body of evidence that the use of biomarkers. no biomarkers (or even a combination of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. during sepsis, gram + and gram - are circulating and often present in small amounts; they can be detected by sensitive and specific tools following a pretreatment of the blood sample (innovative technology bacti-diag). the main objective of the multicentre study bacti-diag-rea is testing in prospectively, in a suspicious population resuscitation of sepsis, this new bacterial biomarker. secondary objectives will assess whether bacti-diag provides time and precision gain (gram + vs grams) in the patient's care including diagnosis and treatment. all icu patients and with clinical criteria of systemic inflammatory response syndrome (sirs) sepsis suspects will be included: in addition to the samples taken for routine care of the patient 4 tubes of whole blood will be collected 5ml. the definitive diagnosis of sepsis or sirs be confirmed retrospectively by two independent experts blinded to bacti-diag. the areas under the roc curves for the detection of gram + and gram will be calculated and associated detection limits will be determined to meet the objectives of the study. it is planned to include 400 consecutive patients with sirs criteria for sepsis 300-360 and analyze biometric and biological data based on the subsequent evolution of the patients. the care of patients will be blinded to the results of the new biomarker bacti-diag


Eligibility criteria:
inclusion criteria: * age\> = 18 years * patient hospitalized in icu with a diagnosis of sirs: * temperatures above 38 ° c or below 36 ° c at least one other criterion from: * heart rate\> 90 bpm * respiratory rate above 20 breaths / min or paco2 \<32 mmhg * leukocytosis greater than or less than 4000/mm3 12000/m3 * patient admitted in intensive care for less than 12 hours * patient does not preclude its participation in the study. exclusion criteria: * no affiliation to a social security scheme (beneficiary or assignee)
allergy immunotherapy in the management of eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: eosinophilic esophagitis (eoe) is a disease that has increased in incidence over the past decade that affects males predominantly, and in adults, is characterized by heartburn, dysphagia, strictures and food impactions. these symptoms may require emergent endoscopic removal of foods and esophageal dilations due to remodeling causing significant impairment in quality of life. treatment options are limited and often not well tolerated or effective. there is poor understanding of the natural history and long term prognosis. it has been associated with allergic sensitization; a high percentage of affected individuals having associated atopy and current literature demonstrates a seasonal distribution of incidence and severity of symptoms. allergy immunotherapy (ait) is a well established and effective treatment for allergic rhinitis and asthma which can induce tolerance to environmental allergens. given the efficacy of ait and the association of aeroallergen sensitization and even seasonal variation of eoe symptoms, we hypothesized that ait may be a treatment option for patients with eoe.

purpose: to evaluate the role of allergy ait in the management of eoe. research design: patients with eoe and aeroallergen sensitization will be offered ait as a treatment modality for eoe. they will be evaluated by questionnaire, laboratory tests, endoscopy and biopsy before and after treatment to determine if there is clinical, laboratory, endoscopic and histologic changes in their eoe.

Eligibility criteria:
inclusion criteria: * eligible for care at naval medical center san diego * diagnosis of eoe (with or without gerd) * positive skin test to aeroallergen(s) * able to provide written informed consent prior to the conduct of any study related procedure exclusion criteria: * all excluding conditions for allergy immunotherapy (ait) - pregnancy, severe asthma, uncontrolled asthma, taking a beta blocker, history of coronary artery disease. (note: age is not typically an exclusion criteria for ait, however this will be an adult only study). * history of significant esophageal disease other than eoe (such as esophageal cancer, surgeries...) * history of other systemic eosinophilic conditions (such as ...) * subjects with controlled asthma on inhaled steroids at the time of diagnosis of eoe may be included , however if a subject develops new asthma or worsening asthma during the study requiring new initiation of inhaled steroids, they may be discontinued to avoid possible swallowing of the medication and "treatment" of their eoe. * if subject is judged by the investigator as unlikely to understand the scope of the study and/or is unlikely to comply with the study procedures and visits. * is currently or has recently been on ait (within the past year)

Keywords: eosinophilic esophagitis environmental allergens allergy immunotherapy tolerance allergic rhinitis asthma seasonal variation
physiologic effect of topical nitroglycerin on microcirculation capacity in patients with circulatory shock.

Conditions: Circulatory Shock; Cardiovascular Shock

Summary: this is an open-label, single center, trial that will enroll up to 25 participants with circulatory shock after cardiac surgery. participants will be administered a topical sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using incident dark field microscopy.


Eligibility criteria:
inclusion criteria: * adult patients receiving elective cabg or valvular surgery requiring cardiopulmonary bypass * receiving postoperative catecholamine therapy to maintain a map \> 65mmhg, cardiac index \> 2 despite initial fluid resuscitation * invasive hemodynamic monitoring exclusion criteria: * surgical hemorrhage * unable to tolerate sublingual microcirculatory flow imaging * known intolerance or allergy to nitroglycerin * inadequate microcirculation imaging (based on massey score)
subcutaneous hydrocortisone children with congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia; Hyperplasia; Adrenal Hyperplasia; Congenital Disorders; Adrenocortical Hyperfunction; Disorders of Sex Development; Urogenital Abnormalities; Genetic Diseases, Inborn; Steroid Metabolic Diseases, Inborn; Adrenal Gland Disease; Hydrocortisone

Summary: this is an open-label, non-randomized crossover design feasibility trial comparing oral hydrocortisone treatment with interval bolus delivery (pulsatile) of subcutaneous hydrocortisone via infusion pump in children with congenital adrenal hyperplasia. eight children, ages 4-18 yrs, will have 24-hr pharmacokinetic and pharmacodynamic profiles of cortisol, 17-hydroxyprogesterone and androstenedione concentrations while on oral hydrocortisone therapy (admission 1), during an initial trial of the subcutaneous hydrocortisone pump (admission 2), and after 6 weeks of subcutaneous hydrocortisone pump treatment (admission 3). an integrated pharmacokinetic and pharmacodynamic model will be used to determine cortisol, 17-hydroxyprogesterone and androstenedione parameters to compare the duration of time subjects have these concentrations outside acceptable ranges. funding source - fda oopd


Eligibility criteria:
inclusion criteria: * children 4 - 18 years of age. * classic congenital adrenal hyperplasia (cah) as confirmed by hormonal and molecular testing. * patients who have been on the same hc dosing regimen for 1 month exclusion criteria: * patients with non-classic cah. * patients on: * dexamethasone * prednisone, or * inhaled steroids. * patients with body surface areas under 1m2 or over 2m2 * non-english speaking patients

Keywords: adrenal gland diseases cortisol succinate hydrocortisone hyperplasia
a study of zidovudine (azt) used alone or in combination with other anti-hiv drugs in hiv-infected patients with little or no previous treatment

Conditions: HIV Infections

Summary: to compare, in zidovudine (azt)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (ro 31-8959) alone versus azt alone versus azt in combination with ro 31-8959, zalcitabine (ddc), or both. to compare various disease markers among the different regimens.

patients are randomized to receive a minimum of 80 weeks of azt alone, azt plus ddc, azt plus ro 31-8959, or all three drugs.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * erythropoietin and g-csf. concurrent treatment: allowed: * local skin radiotherapy. patients must have: * hiv infection. * cd4 count 50 - 350 cells/mm3. * no prior antiretroviral therapy or less than 16 weeks of prior azt. * no acute serious opportunistic infections requiring immediate treatment. * no unexplained fever persisting for 14 days within 90 days prior to study entry. * no significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. * no visceral kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. * life expectancy of at least 80 weeks. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * malabsorption. * severe chronic diarrhea. * inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). * any grade 3 or worse toxicity. * inability to comply with study requirements. concurrent medication: excluded: * other investigational agents. * antineoplastic agents. * biologic response modifiers (including interferons). * foscarnet. * anti-hiv drugs other than the study drugs. concurrent treatment: excluded: * radiotherapy (other than local skin radiotherapy). patients with the following prior condition are excluded: history of non-hodgkin's lymphoma. prior medication: excluded: * acute therapy for opportunistic infection within 14 days prior to study entry. * prior hiv proteinase inhibitor.

Keywords: drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine saquinavir hiv protease inhibitors
we analyse metabolites in dried blood spots from newborns that later in life developed an eating disorder.

Conditions: Eating Disorders

Summary: anorexia nervosa (an) and bulimia nervosa (bn) are serious eating disorders (eds) with significant morbidity and mortality. genetic studies have shown associations between eds and metabolic traits, and longitudinal studies indicate distinct weight trajectories in children who later develop an or bn, suggesting early involvement of metabolic factors. biological studies also reveal differences in immune and neurotrophic markers in individuals with eds compared to controls. intriguingly, metabolites measured in neonatal blood could serve as very early markers of ed risk, unconfounded by state or scar factors related to prolonged starvation. here the investigators propose to comprehensively analyze neonatal biomarkers (metabolic, immune, and neurotrophic), epidemiological factors, and genetics to understand ed risk and develop risk prediction models


Eligibility criteria:
inclusion criteria: - in pku-register with or withou life-time diagnosis of anorexia or bulimi nervosa exclusion criteria: * not in pku register
microbiota in chronic anal fissure and its association with prognosis

Conditions: Anal Fissure; Microbial Colonization

Summary: in this study, we will try to answer the following questions: 1. what are the salient features of the microbiota in chronic anal fissure? 2. are these features associated with prognosis and response to therapy? 3. does an anal fissure swab and anal fissure tissue give comparable bacteriological results?

to allow rational planning of therapeutic trials of antimicrobial or biofilm degrading medical therapy, a better understanding of the microbiota of chronic anal fissures is needed. previous studies have relied on culture, whereas we will employ molecular methods. we will collect bacteriological samples from patients referred to us with anal fissure, in order to characterize the microbiota. to see if the microbiota is distinct from or similar to the rectal microbiota, we will also collect a swap from the rectum. we will also collect swaps from the anal verge of healthy volunteers without anal fissure, to see if the microbiota in anal fissures are distinct from the normal anodermal microbiota. to examine whether a swap is a reliable method for characterizing the microbiota in anal fissure, we will also collect excised anal fissure tissue from the subset of patients with a clinical indication for fissurectomy in general anaesthesia, and compare the analysis results with those from the swap. we will re-assess the patients clinically and with a repeat swap after 3 months, and perform an exploratory analysis in order to identify possible features of the microbiota that are associated with poor response to therapy.

Eligibility criteria:
inclusion criteria three samples will be included: 1. consecutive patients referred to the outpatient clinic at the digestive disease centre, bispebjerg hospital in denmark for botox injection for chronic anal fissure. thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy 2. consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia 3. healthy volunteers. these will be recruited among staff at the digestive disease centre, bispebjerg hospital, denmark. samples 1 and 2 will not be independent, as patients from group 1 may be included in group 2 depending on the clinical course. no direct comparisons between these two groups are planned (see analysis section). exclusion criteria * symptom duration of less than 8 weeks (groups 1 and 2) * known or suspected crohn's disease * known or suspected active venereal disease.
robotic-assisted laparoscopic sacrocolpopexy

Conditions: Pelvic Organ Prolapse

Summary: robotic-assisted abdominal sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.

robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12x magnification, 4) 3-d depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. with robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. to date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assistance. there have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.

Eligibility criteria:
inclusion criteria: * non-pregnant women * age \>18 years * eligible for sacrocolpopexy * prior hysterectomy * stage ii or greater post hysterectomy vault prolapse * satisfied parity * patients electing for an abdominal repair to posthysterectomy vault prolapse exclusion criteria: * prisoners * cognitively impaired adults * not medically stable to undergo laparoscopic or abdominal surgery * previous pelvic/vaginal radiation * participants electing to proceed with a vaginal repair of vaginal vault prolapse * participants electing to proceed with the traditional abdominal sacrocolpopexy * history of recurrent vaginal infections * known urologic and/or gynecologic cancer

Keywords: pelvic organ prolapse robotic-assisted laparoscopic sacrocolpopexy post hysterectomy prolapse symptomatic apical prolapse of stage ii or >
timing of dietary acid intake, brushing teeth and acid erosion.

Conditions: Tooth Wear

Summary: this is a questionnaire based study investigating the relationship between the timing of dietary acid intake toothbrushing and erosive tooth wear. data will be collected on the timing, nature, frequency and duration of dietary acid intakes and timing and frequency of the participants toothbrushing. signs of the participants erosive tooth wear will then be recorded

the study group will consist of two cohorts, those presenting with tooth wear and a control group. participants will be recruited from the care planning clinic of the dental institute king's college london. suitable participants meeting the inclusion criteria will be approached on the clinic, given the patient information sheet and asked to consider participating. written consent will be obtained from those accepting the request. an interviewer-led, previously validated questionnaire will question their frequency and timing of dietary acid intake, tooth brushing and any habits associated with dietary acid intake. this will be followed by a basic erosive wear examination. the process will take 7-8 minutes and the participant is free to withdraw at any time

Eligibility criteria:
inclusion criteria: 1. severe tooth wear with a bewe score of 12 and at least one score of 3 in three quadrants 2. adult 18 years or older 3. no missing anterior teeth 4. minimum of at 10 teeth in the upper and 10 teeth in the lower jaw 5. no anterior crowns/ bridges or implants 6. written consent to the study exclusion criteria: 1. pregnancy 2. participation in other research within 30 days 3. unable to speak or understand english 4. presence of periodontal disease or caries on more than one tooth
brain oxygenation marker for cognitive function in healthy adults

Conditions: Mental Fatigue

Summary: this study aims to identify a cortical oxygenation marker for cognitive function using functional near infrared spectroscopy in healthy adults.

this study will aim to establish a model between the cortical oxygenation and cognitive performances given modulations by experimental conditions including the cognitive workload and the time-on-task, and individual variabilities such as the age or the gender.

Eligibility criteria:
inclusion criteria: 1. males and females 25-45 years old 2. bmi between 18.5 kg/m2 and 29.9 kg/m2 3. conditions for study procedure compliance: * willing and able to sign an informed consent form * be fluent in english (self-reported c1 or c2 english level) * be able to provide a cortical oxygenation signal (based on feasibility to fix the measurement device on the scalp, which can be altered by hair thickness) * be dominant right-handed * have a normal or corrected-to-normal vision * be expected to comply with the protocol exclusion criteria: the project exclusion criteria are: 1. conditions that may affect cortical oxygenation: * be insomniac (insomnia severity index, isi, higher than 15 based on rating at the medical screening) or night shift worker (based on anamnesis) * be currently diagnosed with migraine (based on anamnesis) * be currently diagnosed with hypo- or hyper-tension (based on evaluation of bp measure against medical norms at the medical screening) * have an historical or current neural, cerebrovascular, cardiovascular, or respiratory disease (based on anamnesis) * have a heavy usual consumption of caffeine-based beverages i.e., more than 5 servings of caffeinated coffee/colas or tea or 1 serving of caffeinated energy drinks per day * be a regular smoker (regularly defined as greater than 2 cigarettes per week) * participate in a vigorous physical activity requiring more than 6 metabolic equivalents e.g., hiking, jogging at 10 km/h or more, carrying of heavy loads, bicycling fast at 23 km/h or more, basketball, soccer, and tennis single, greater than 4 times 45 minutes per week 2. conditions that may affect cognition or the mental fatigue * take illicit drugs (for e.g., cannabis, heroin, and cocaine) * have an average alcohol consumption greater than 2 standard drinks per day over a week for males, and greater than 1 standard drink per day over a week for females. one standard drink contains 10-12 g of ethanol. examples of standard drinks are one beer can (300 ml), one glass of wine (100 ml) or one glass of schnaps (30 ml). * have a psychiatric disorder or be currently diagnosed with anxiety or depression * be pregnant (verified by a pregnancy test in urine dipstick format) or seeking to become pregnant or breast feeding 3. have a hierarchal or family relationship with any of the research team members. 4. currently participating in another interventional study.

Keywords: cortical tissue oxygenation cognition time-on-task functional near infrared spectroscopy